The Impacts of Adverse Provider Conditions on Medical Decision-Making and Patient Care
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Testing Automatic Judgments: "Implicit Association Test"
研究概览
简要总结
This is a randomized, double-blind clinical trial involving emergency medicine and internal medicine healthcare providers as participants. The intervention involves the administration of the seasonal influenza vaccine or a saline placebo; this protocol is used in psychoneuro-immunology to simulate a state of mild illness. The primary aim is to examine whether acute inflammation induced by receiving the vaccine affects decision-making on standardized psychological reaction time tasks and questionnaires. Participants attend two laboratory sessions on consecutive days, receive either a seasonal influenza vaccine or a saline placebo at the first session, provide blood samples to measure inflammatory cytokines, and complete a series of standardized assessments of medical decision-making and social attitudes. Participants who received the placebo during the first session will receive the vaccine during the second session.
Overall, the study is designed to examine how adverse provider conditions particularly acute inflammation, burnout, and concerns about one's own health affect provider judgments and healthcare-related decision-making. The primary hypothesis is that providers experiencing greater adverse conditions at the time of research participation would have altered decision-making compared to those experiencing fewer adverse conditions.
详细描述
Participants will provide informed consent during a call (Zoom, Teams, Phone) with the University of Arkansas research team. The research team member will explain the study procedures to the participants and will give them the opportunity to ask questions. During the call, they will review the electronic consent form and will sign the form after all of their questions have been answered. They will receive a paper copy of the consent documents to review one more time when they arrive at the first research session at their site.
Participants will complete two lab sessions on consecutive days (scheduled as close to 24-hours apart as possible) at a collaborating research site. At each site, a member of the local team will coordinate the sessions, including providing instructions before participants complete various study tasks. During each session, participants will complete standardized measures of decision-making that will allow us to comprehensively document how adverse provider conditions (acute inflammation, burnout, stress, concern about own health) affect objectivity in decision-making across multiple domains. These standardized measures include reaction time tasks and questionnaires. Participants will also complete questionnaires that assess demographic information, personality information, and questions about their experiences with adverse provider conditions (burnout, stress, other workplace demands, mood, concerns about own health). During each session, participants will provide blood samples (~3mL) that will be assayed for pro-inflammatory cytokines interleukin-6 and interleukin-1beta. Participants will be randomly assigned to either the experimental or control condition using stratified permuted block randomization. Those in the experimental condition will receive the influenza vaccine at the end of Session 1 and those in the control condition will receive a saline placebo injection instead. We will use a double-blind design so that neither the participant nor the research assistant administering the decision-making tasks will know the condition.
At the end of the second session, participants will be debriefed and informed about the condition they were assigned to (up until this point, the research coordinator and participant will be blind to participant condition). Those in the control condition will receive the vaccine before they leave.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare providers currently employed in emergency medicine or internal medicine
- •Must be one of the following: Resident, fellow, attending, or advanced practice provider (NP, PA)
- •Individual is able to travel to the research site for sessions
- •Has not had an acute viral or bacterial infection within the previous 14 days
- •Has not taken an antiviral medication such as Tamiflu in the previous 48 hours
- •Has not taken corticosteroids or immunosuppressants in the previous 30 days
排除标准
- •Does not want to receive a flu vaccine as part of the study
- •Has received a flu vaccine this season already (after August of current year)
- •Has had a prior allergic reaction or bad side effect, including Guillain-Barre, due to a flu vaccine or another vaccine
- •Is allergic to eggs or have had an adverse reaction to egg-derived vaccine
- •Is pregnant or suspects a possible pregnancy
- •Has congenital or acquired immunodeficiency such as common variable immunodeficiency (CVID) or HIV/AIDS
- •Has an active hematologic malignancy (like leukemia, lymphoma, myeloma)
- •Has Type 1 diabetes
- •Has Graft vs. Host Disease
- •Uses aspirin, ibuprofen (i.e., NSAIDs), acetaminophen, or naproxen daily
- •Uses corticosteroids or immunosuppressants daily
- •Is currently receiving systemic chemotherapy and/or immunotherapy
- •Has had changes in daily prescription medication in the last 3 months (starting, stopping, changing dose)
研究组 & 干预措施
Placebo Injection
Receives a saline placebo injection at the end of Session 1
干预措施: Placebo (Other)
Influenza Vaccine Injection
Receives the influenza vaccine at the end of Session 1
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
Testing Automatic Judgments: "Implicit Association Test"
时间窗: 2 days
This task calculates a "d" score across trials to quantify the strength of implicit associations. Higher d scores indicate more negative automatic attitudes.
Testing Deliberate Judgments: "Feeling Thermometers"
时间窗: 2 days
Explicit attitudes are assessed via 100-point Feeling Thermometers that ask for feeling toward different patient groups. Lower values indicate more negative attitudes.
次要结局
- Questionnaire Assessing Social Avoidance: "Patient Sorting Task"(1 day)
- Questionnaire Assessing Perception of Others' Pain: "Threshold for Detecting Pain on Faces"(2 days)
- Questionnaire Assessing Cognitive Depletion: "Stroop Task"(2 days)
- Questionnaire Assessing Motivation: "Motivation to Respond without Prejudice Scale"(2 days)